BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBULINK(R) SYNDESMOSIS REPAIR KIT/TI

    MDR report key: 20256228 · Received September 19, 2024

    Report

    Report Number
    8030965-2024-11781
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    September 11, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTN
    UDI-DI
    07612334226365
    PMA / PMN Number
    K173550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: ADDED: D6A DEVICE HISTORY REVIEW: PART # FGS-1100 SYNTHES LOT # 22E013 SUPPLIER LOT # 22E013 RELEASE TO WAREHOUSE DATE: 27 JUN 2022 SUPPLIER: (B)(4). NO NCR'S GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF (OPEN REDUCTION INTERNAL FIXATION) WITH FIBULINK FOR A DISLOCATED ANKLE FRACTURE. THE FIBULINK WAS USED AS PER PROCEDURE. THIS WAS THE FIRST USE FOR THE SURGEON. THE TIBIA SCREW WAS INSERTED. THE SILVER GUIDE TUBE WAS PASSED THROUGH THE TENSIONING CAP, AND THE SILVER GUIDE TUBE WAS GRASPED WITH FORCEPS. THEN, THE SILVER GUIDE TUBE WAS GENTLY PULLED LATERALLY WHILE WATCHING THE IMAGE. DESPITE REPEATEDLY PULLING THE SILVER GUIDE TUBE LATERALLY TO DEPLOY THE FIBULA LINK, THERE WAS NO CHANGE IN THE FIBULA LINK ON THE IMAGE. THE SURGEON ROTATED THE TENSIONING CAP, AND IT DID NOT MATCH. ALTHOUGH THE SAME PROCESS WAS REPEATED, THE TENSIONING CAP DID NOT MATCH AT ALL. WHEN THE SURGEON PULLED THE SILVER GUIDE TUBE HARD, THE SILVER GUIDE TUBE CAME LOOSE. THE SURGEON STRUGGLE WITH REINSERTING THE SILVER GUIDE TUBE. DURING INSERTION, THE FIBULA LINK WAS HIGHLY UNSTABLE AND COULD NOT BE PLUGGED IN. THIS CAUSED SURGICAL DURATION. SINCE IT TOOK A LONG TIME, REMOVAL INSTRUMENTS AND A NEW FIBULINK WAS PREPARED TO REDO. ALTHOUGH THE SURGEON TRIED TO REMOVE THE FIBULA LINK AND THE TIBIA SCREW, THE FIBULA LINK HAD A CONSIDERABLE GAP AND THE SCREWDRIVER WAS DIFFICULT TO INSTALL. THE SURGEON MANAGED TO REMOVE IT WITH DIFFICULTY. A NEW FIBULINK HAD NO PROBLEM. THE FIBULA LINK PULLED LIGHTLY AND WAS DEPLOYED SUCCESSFULLY. THEN, TENSION WAS APPLIED WITH THE TENSIONING CAP, AND THE PROCEDURE WAS COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE SURGICAL DELAY WAS 40 MINUTES. IT WAS CONFIRMED THAT THERE WAS NO PERMACORD SUTURE BRIDGE IN THE FIBULINK. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503852 FIBULINK(R) SYNDESMOSIS REPAIR KIT/TI WASHER, BOLT NUT HTN SYNTHES GMBH 22E013 07612334226365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown